The following data is part of a premarket notification filed by Nobel Biocare Usa Llc with the FDA for Zygoma Tiunite.
| Device ID | K050641 |
| 510k Number | K050641 |
| Device Name: | ZYGOMA TIUNITE |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Elizabeth Mason |
| Correspondent | Elizabeth Mason NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-14 |
| Decision Date | 2005-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747013528 | K050641 | 000 |
| 07332747003178 | K050641 | 000 |
| 07332747003161 | K050641 | 000 |
| 07332747160222 | K050641 | 000 |
| 07332747160215 | K050641 | 000 |
| 07332747160208 | K050641 | 000 |
| 07332747160192 | K050641 | 000 |
| 07332747160185 | K050641 | 000 |
| 07332747160178 | K050641 | 000 |
| 07332747160161 | K050641 | 000 |
| 07332747003185 | K050641 | 000 |
| 07332747003192 | K050641 | 000 |
| 07332747003208 | K050641 | 000 |
| 07332747013511 | K050641 | 000 |
| 07332747013504 | K050641 | 000 |
| 07332747013498 | K050641 | 000 |
| 07332747013481 | K050641 | 000 |
| 07332747013474 | K050641 | 000 |
| 07332747013467 | K050641 | 000 |
| 07332747013450 | K050641 | 000 |
| 07332747003864 | K050641 | 000 |
| 07332747003857 | K050641 | 000 |
| 07332747160154 | K050641 | 000 |